Our client is a renowned pharmaceutical company dedicated to advancing healthcare and improving patients’ lives. With a strong emphasis on research and development, focus on discovering innovative solutions for a wide range of medical conditions. They are actively exploring therapeutic areas including oncology, cardiovascular diseases, autoimmune disorders, bone health, and neurology, among others.
This role requires embed Good Distribution Practices and Falsified Medicines Directive principles into the EU Regional Supply Chain network, oversee temperature and deviation records, lead root cause analyses, manage CAPA and CAPA EV records, handle missing product notifications, support audits, product recalls, and document management, while maintaining updated Smartsheets, the Supply Chain Distribution manual, and occasionally traveling.
– Maintain and oversee records for temperature assessments (CTETS).
– Administer and oversee Corrective and Preventive Action (CAPA) and CAPA Effectiveness Verification (EV) records, ensuring their proper implementation.
– Provide support for audits and inspections related to the EU supply chain, including those conducted at the affiliate level.
– Assist in activities related to product recalls and annual mock recall exercises.
– Occasional travel may be required.
– Ensure that Smartsheet’s for minor deviations, major deviations, CTETS, and missing products are kept up to date.
– Take ownership of the Supply Chain Distribution manual.
– A Bachelor’s degree in Life Sciences and two years of experience in GMP/GDP compliance or you should have at least four years of experience in GMP/GDP compliance.
– Good understanding of Quality Assurance principles, Good Manufacturing Practice, and Good Distribution Practice.
– Fluent in both English and Dutch is a plus.
– Skilled in word processing, databases, spreadsheets, and have experience with Quality Management Software systems.
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
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